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Quality Assurance Site Head / Director Quality Assurance

Company: Abbott
Location: San Diego
Posted on: October 13, 2019

Job Description:

Position Title: Quality Assurance Site Head/Director Quality Assurance

Location: San Diego, CA
DO WORK THAT MATTERS

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 160 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
WHY IS THIS POSITION IMPORTANT?

We have an exciting opportunity for a Site Quality Head within our Toxicology Manufacturing Site located in San Diego, CA. In this role you will help shape the future of quality journey and create something special within the broader Abbott network.

Abbott Rapid Diagnostics (formerly Alere) is part of Abbotts Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
POSITION SUMMARY

* Acts as Quality Assurance Site Head, with overall responsibility for ensuring product safety, reliability and quality.

* Leads a highly technical QA team Quality Specialists, Quality Engineers and Analysts.

* Ensures that processes and staffing are appropriately developed and implemented to maintain the quality system

* Sets strategic vision/goals in alignment with site organization and division, ensure compliance within organization to all applicable internal requirements and external regulations

* Establishes quality systems and plans to assure manufacturing of the highest quality products to exceed customer requirements. Interfaces with outside regulatory agencies as an Abbott representative. Failure to adequately perform tasks can result in non-compliance with governmental regulations


MAIN RESPONSIBILITIES

* Recruits, coaches and develops organizational talent. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

* Provides direction to managers, exempt specialists and non-exempt support in various areas, groups and/or operations.

* Keeps the organization's vision and values at the forefront of decision making and action.

* Demonstrates effective change leadership.

* Builds strategic partnerships to further departmental and organizational objectives.

* Supports operations in continuous improvement initiatives by providing direction on process validation/verification requirements for proposed changes.

* Support New Product Initiatives as a Core Team Member supporting design control and design transfer projects.

* Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers.

* Coordinates across functional areas, business units, and/or geographies in order to achieve company or area goals.

* Utilizes technical/professional knowledge and skills to establish, interpret and execute company policies

* Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA).

* Makes and executes operational decisions with a strategic perspective.

* Directs and controls the activities and budget of site QA functional operations.

* Establish Quality Systems that are in compliance with regulatory requirements and meet business needs.

* Reviews, analyzes and presents to senior staff and other groups the effectiveness of the Quality System.

* Recommends and implements changes to the system as the result of changing regulations and/or business needs.

* Analyzes data, makes decisions or provides recommendations to senior staff regarding quality related crises (e.g. product malfunction, field actions, production hold, customers complaints).

* Communicates quality policies, strategies and procedures to the organization through written documents, presentations and discussions.

* Acts as Site Management Representative.

REQUIREMENTS

To be considered an applicant for this position you must show how you meet the basic qualifications of the job in a resume or document you upload, or by completing the work experience and education application fields. Accepted file types are Microsoft Word (DOC or DOCX), PDF, HTML, or TXT.

BASIC QUALIFICATIONS

* Bachelors Degree in Life Sciences or Engineering

* 10 years of related work experience in Quality Assurance with at least 5 years in a Quality Assurance site leadership role.


PREFERRED QUALIFICATIONS

* Masters Degree or MBA

* IVD background preferred, Medical Devices/Pharma/Biotech background is also acceptable

* Proven success track in

* Progressing department and site toward divisional and company goals

* Monitoring all costs associated with assigned organizational unit

* Monitoring industry trends and external environment in areas relevant to the assigned organizational unit

* Being a subject matter expert and able to lead a team of technical experts in CAPA, QMS, SOP, Design Control, Verification and Validation

* Developing and/or identifying new work processes that will have broad applicability throughout the company

* Supporting new product development initiatives and successfully supporting products from feasibility to design transfer and commercialization

* Conducting root cause analysis on highly technical problems and solving problems that impact work processes and personnel in multiple units or departments


ABOUT ABBOTT

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

AN EQUAL OPPORTUNITY EMPLOYER, ABBOTT WELCOMES AND ENCOURAGES DIVERSITY IN OUR WORKFORCE.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to myrecruiter@alere.com.

Keywords: Abbott, San Diego , Quality Assurance Site Head / Director Quality Assurance, Executive , San Diego, California

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